# FDA recall Z-2103-2018

> **NordicNeuroLab AS** · Class II · device recall initiated 2017-10-28.

## Product

fMRI Hardware System - AudioSystem, Version 1.0    The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

## Reason for recall

Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

## Distribution

Worldwide Distribution - USA (nationwide) and to the countries of :  Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria

## Key facts

- **Recall number:** Z-2103-2018
- **Recalling firm:** NordicNeuroLab AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-28
- **Report date:** 2018-06-13
- **Termination date:** 2021-03-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bergen, N/A, Norway

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2018

## Citation

> AI Analytics. FDA recall Z-2103-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2103-2018. Source: US FDA. Licensed CC0.

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